Clinical trial · Observational
Antegrade Observational Comparative Study for the Intravesical Instillation Therapy of Bacillus Calmette Guerin With the Use of Different Types of Urinary Catheters in Patients With Urinary Bladder Cancer
NCT05675176CI-TRIAL-00063145completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study compares the complications caused after the BCG intravesical instillation in patients treated for non invasive bladder cancer.The patients are divided into two groups one receiving IVI (intravesical Instillations) with the use of latex catheter while in the other silicone catheter is used.The two groups are compared in terms of fever, hematuria, LUTS and other complications following IVI.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-muscle-invasive Bladder Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group 1
- description
- Patients with non muscle invasive bladder cancer undergoing intravesical instillation with the use of self lubricated silicon tiemann 10 fr urinary catheter.
- interventionNames
- Drug: BCG
- label
- Group 2
- description
- Patients with non muscle invasive bladder cancer undergoing intravesical instillation with the use of straight tipped latex foley 14 fr urinary catheter
- interventionNames
- Drug: BCG
Primary outcomes (1)
- measure
- Complications
- timeFrame
- 1.5 year
- description
- Complications in both groups- hematuria, fever, LUTS , systemic symptoms
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * BCG intravesical instillation for non muscle invasive bladder cancer Exclusion Criteria: * Positive culture * Preexisting LUTS * Muscle invasive bladder cancer
References
Publications (4)
- BACKGROUNDNacey JN, Tulloch AG, Ferguson AF. Catheter-induced urethritis: a comparison between latex and silicone catheters in a prospective clinical trial. Br J Urol. 1985 Jun;57(3):325-8. doi: 10.1111/j.1464-410x.1985.tb06354.x. PMID 3891005
- BACKGROUNDStenzelius K, Persson S, Olsson UB, Stjarneblad M. Noble metal alloy-coated latex versus silicone Foley catheter in short-term catheterization: a randomized controlled study. Scand J Urol Nephrol. 2011 Sep;45(4):258-64. doi: 10.3109/00365599.2011.560007. Epub 2011 Mar 31. PMID 21452931
- BACKGROUNDLiu Y, Lu J, Huang Y, Ma L. Clinical Spectrum of Complications Induced by Intravesical Immunotherapy of Bacillus Calmette-Guerin for Bladder Cancer. J Oncol. 2019 Mar 10;2019:6230409. doi: 10.1155/2019/6230409. eCollection 2019. PMID 30984262
- RESULTTalja M, Korpela A, Jarvi K. Comparison of urethral reaction to full silicone, hydrogen-coated and siliconised latex catheters. Br J Urol. 1990 Dec;66(6):652-7. doi: 10.1111/j.1464-410x.1990.tb07203.x. PMID 2265339